Novartis' Ilaris fails in late-stage COVID-19 trial

Novartis’ Ilaris (canakinumab) has failed to produce results in a phase 3 trial, which tested whether it could improve COVID-19 patients’ survival chances without need for mechanical ventilation.

The company is trying to repurpose the drug used in rare inflammatory diseases such as juvenile arthritis for COVID-19, to see if it could relieve the extreme immune reaction that can prove fatal after infection with coronavirus.

But results from the CAN-COVID trial showed that Ilaris also missed an important secondary goal of reduced COVID-19 mortality compared with standard therapy.

In the trial involving 454 patients in the US, Russia and Europe, the primary endpoint of survival without the need for mechanical ventilation was 88.8% for canakinumab plus standard care compared with 85.7% for placebo plus standard care.

The key secondary endpoint was to reduce the COVID-19-related death rate during the four week period after trial treatment.

While the data trended in Ilaris’ favour against both targets, the effect seen was not marked enough to be statistically significant.

Novartis noted that the results from this trial do not affect Ilaris’ licensed indications or other trials and the safety profile was comparable to placebo plus standard of care.

An interim analysis will be submitted to a peer-reviewed journal in the coming weeks.

The company said the focus in COVID-19 moves to Jakavi/Jakafi (ruxolitinib), which is in a phase 3 trial and is another attempt to repurpose an already approved drug – Jakafi is already approved in indications including myelofibrosis.

Novartis is also working with Molecular Partners to develop therapies based on genetically engineered proteins known as DARPins.

These are small proteins that are created in the lab but mimic the effect of antibodies and could be used to neutralise the SARS-CoV-2 coronavirus that causes COVID-19.

There have been countless efforts to repurpose existing drugs to fight COVID-19, with the most successful arguably being dexamethasone.

The cheap steroid has been shown to reduce inflammation caused by the disease in the UK’s large RECOVERY trial, which is testing several already licensed drugs against COVID-19.